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Migraine Prophylaxis With Clopidogrel Trial

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ClinicalTrials.gov Identifier: NCT02938182
Recruitment Status : Not yet recruiting
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Brief Summary:
The underlying mechanisms of association between the right-to-left shunts (RLS) and migraine may concern with platelet aggregation and paradoxical embolization. The aim of the study is to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with RLS.

Condition or disease Intervention/treatment Phase
Migraine Drug: clopidogrel Phase 4

Detailed Description:
Many studies have shown an increased prevalence of right-to-left shunts in migraineurs. The underlying mechanisms of association between the right-to-left shunts (RLS) and migraine may concern with platelet aggregation and paradoxical embolization. In the present study, migraineurs without taking prophylactic medicines regularly will be given only clopidogrel 75 mg daily for three months. Migraineurs who are unresponsive to at least two commonly applied preventive medications, clopidogrel 75 mg daily will be added to his/her existing prophylactic migraine regimen for three months. Patients will be followed up at the third month and the sixth month for headache frequency, attack duration of headache, migraine disability assessment scale(MIDAS)scores, headache impact test(HIT-6)scores and visual analogue scale(VAS)scores. Investigators will evaluate the changes of these measurements between baseline and the follow-up time. The aim of the study is to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with RLS.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Trial to Evaluate the Effectiveness of Clopidogrel to Relieve Migraine With Right-to-left Shunt
Study Start Date : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: clopidogrel
clopidogrel tablet 75mg daily for three months
Drug: clopidogrel
clopidogrel troche 75 mg daily for three months
Other Name: plavix




Primary Outcome Measures :
  1. Change from Baseline Attack Duration of Headache at three months, h [ Time Frame: three months ]

Secondary Outcome Measures :
  1. Change from Baseline Headache Frequency per Month at three months, time [ Time Frame: three months ]
  2. Change from Baseline Visual Analogue Scale at three months, scores [ Time Frame: three months ]
  3. Change from Baseline Migraine Disability Assessment Scale at three months, scores [ Time Frame: three months ]
  4. Change from Baseline Headache Impact Test at three months, scores [ Time Frame: three months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • migraine with or without aura diagnosed by a neurologist according to the criteria of the International Headache Society (3nd edition)
  • experience a minimum of two migraine attacks per month in a 3-month baseline phase
  • without regular use of prophylactic treatments or unresponsive to two and more commonly applied preventive medications
  • the presence of RLS confirmed by contrast-enhanced transcranial Doppler
  • no positive findings in cranial CT and MRI

Exclusion Criteria:

  • other types of headaches
  • systemic chronic diseases, cerebrovascular disease, abnormal platelet or liver function
  • history of head injury
  • other contraindications to clopidogrel treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938182


Contacts
Contact: Guogang Luo, doctor 0086-13991974085 lguogang@163.com
Contact: Dan Zhu, master 0086-15229233307 767441726@qq.com

Locations
China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University Not yet recruiting
Xi'an, Shaanxi, China, 710061
Contact: Guogang Luo, doctor    0086-13991974085    lguogang@163.com   
Contact: Dan Zhu, master    0086-15229233307    767441726@qq.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
Principal Investigator: Guogang Luo, doctor First Affiliated Hospital Xi'an Jiaotong University

Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02938182     History of Changes
Other Study ID Numbers: XJTU1AF-CRS-2016-019
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The information of the patients need to keep confidential.

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors